Phase III safety study of Brixadi in opioid-use disorder published in Addiction journal.

Braeburn Inc. announced the publication of its 48-week, open-label, multi-center, global Phase III long-term safety study of once weekly and once monthly Brixadi (buprenorphine fluid crystal injection) in a substance use disorder journal, Addiction. The study evaluated the long-term safety of Brixadi , as well as other measures of effectiveness in both new-to-treatment patients and patients transferring from daily standard-of-care with sublingual buprenorphine or buprenorphine/naloxone. The study enrolled 227 patients from 26 clinical sites across the United States, the United Kingdom, Hungary, Denmark, Sweden, Germany and Australia. In total, 167 patients (73.6%) completed the 48 weeks of treatment, with over 5,000 injections of Brixadi administered.

More than 80% of the patients who transitioned from daily sublingual buprenorphine treatment stated that Brixadi was "much better" or "slightly better" than their previous treatment. Furthermore, Brixadi weekly and monthly were effective in reducing opioid withdrawal and cravings and maintaining low withdrawal and craving scores. The degree of abstinence at the end of the treatment period was high, with 63.0% (17/37) of new-to-treatment participants and 82.8% (111/190) of patients converted from sublingual buprenorphine having negative urine tests plus negative self-reports for illicit opioid use.

Additionally, Brixadi was well tolerated and demonstrated a systemic safety profile similar to sublingual buprenorphine. The most common adverse events (AEs) occurring in at least 5% of participants were pain, swelling, or erythema at the injection site; nasopharyngitis; headache; nausea; urinary tract infection; and vomiting. Injection site reactions were reported for 20.3% of patients, with most (97.8%) reported as mild to moderate. Serious AEs were experienced by 5.3% of patients of which none were related to study medication. As in the Phase III efficacy study, no opioid overdoses were reported for patients treated with Brixadi.

See: "Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder" Michael Frost et al. Addiction 23 April 2019 https://doi.org/10.1111/add.14636